REPORT

Pharma 4.0 and drivers of change

New technologies — and other trends impacting validation teams — dramatically re-shaped the validation landscape. From remote assessments to Pharma 4.0, here’s what validation teams had to say in 2024.

KEY 2024 TAKEAWAYS:

  • 64% of teams were using or adopting CSA processes

  • 29% of organizations allocate 10% or more of a project budget to validation

  • 75% had some form of remote audit in the past 12 months

  • Pharma 4.0 remains in the early stages of adoption

Validation Industry Insight

About the 2024 Author

Jonathan Kay

Jonathan Kay is a trusted advisor to life sciences and digital health companies. He has supported the successful development, launch, and commercialization of dozens of medical devices, diagnostics, vaccines, and therapeutics to address unmet needs in cancer, cardiovascular disease, infectious disease, rare disease, and more. His mission is to advance new technologies that save and improve lives and expand access, equity, and value. He does that by helping industry to understand complex landscapes through market research. In 1999, Jonathan co-founded one of the first online medical market research firms, helping to digitally transform that industry. He has served in leadership roles in the US and globally in WPP agencies, including PSB Research, where he formed the healthcare practice and led it for a decade, TNS Healthcare, and Kantar Health (now Cerner Enviza / Oracle).

Jonathan earned a B.A. from Cornell and a Master in Public Policy from the Harvard Kennedy School of Government. He is fascinated by the application of artificial intelligence to healthcare and completed studies of ‘Artificial Intelligence: Implications for Business Strategy’ at MIT. Jonathan is also a board member of the Brem Foundation to Defeat Breast Cancer and a volunteer mentor to CEOs of start-ups at the Maryland Tech Council.